Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Tactile Medical
Subjects will be randomized to receive either the ACTitouch system or standard compression garments, and will respond to symptom surveys and quality of life surveys to assess comfort and ease of use of each. These will be conducted at Baseline, at Day 15 and Day 30.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Diagnosis of unilateral or bilateral CVI with or without leg ulcers
Documented history of low adherence to compression garment therapy
CEAP classification C3-C6
Leg circumferences within the following ranges: Ankle 12-44cm, calf 22-6m, below the knee 22-68cm
You may not be if
History of skin sensitivity to any of the components of ACTitouch or compression garments
History of acute (deep vein thrombosis) DVT or (pulmonary embolism) PE within the last 3 months
Ankle Brachial Index (ABI) \< 0.8
Acute thrombophlebitis
History of pulmonary edema or decompensated congestive heart failure
Currently has an active infection of the skin such as cellulitis requiring antibiotics
Poorly controlled diabetes with an HbA1c value of \>10%
Exhibits any condition which, according to the PI, justifies the subjects exclusion from the study, such as a medical condition where an increase in venous or lymphatic return is undesirable.
Subjects with open ulcers must be able to follow their care regimen for ulcer healing concurrently with the assigned study regimen.
Participating in another clinical trial
Changes to medications that affect edema within the last 30 days
Currently pregnant or trying to become pregnant
Clareo Health | Evaluation of a Dual Action Pneumatic Compression Device: Patient Ease of Use and Comfort
